NCT00760565

Brief Summary

This single center, multiple ascending dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO4905417 at different doses in healthy volunteers and patients with peripheral arterial disease. Three groups of 10 healthy volunteers will receive RO4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total of 3 infusions. In addition, two groups of 6 PAD patients will receive RO4905417 (either 3mg/kg, 7mg/kg) or placebo and 1 group of 20 PAD patients will receive 20mg/kg RO4905417 or placebo iv every 28 days for a total of three infusions. The study will have an adaptive design with ongoing assessment of safety and tolerability prior to initiation of the next dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 28 day intervals. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

Typical duration for phase_1

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.7 years

First QC Date

September 25, 2008

Last Update Submit

November 1, 2016

Conditions

Peripheral Arterial Disease (PAD)

Outcome Measures

Primary Outcomes (1)

  • Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.

    Throughout study

Secondary Outcomes (2)

  • Pharmacodynamics: bleeding time; protein/vascular markers

    Throughout study

  • Pharmacokinetics of RO4905417

    Throughout study

Study Arms (12)

1

EXPERIMENTAL
Drug: RO4905417

10

PLACEBO COMPARATOR
Drug: placebo

11

EXPERIMENTAL
Drug: RO4905417

12

PLACEBO COMPARATOR
Drug: placebo

2

PLACEBO COMPARATOR
Drug: placebo

3

EXPERIMENTAL
Drug: RO4905417

4

PLACEBO COMPARATOR
Drug: placebo

5

EXPERIMENTAL
Drug: RO4905417

6

PLACEBO COMPARATOR
Drug: placebo

7

EXPERIMENTAL
Drug: RO4905417

8

PLACEBO COMPARATOR
Drug: placebo

9

EXPERIMENTAL
Drug: RO4905417

Interventions

RO4905417DRUG

3mg/kg iv every 28 days for 3 infusions

13
placeboDRUG

3mg/kg iv every 28 days for 3 infusions

24

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy males and females aged 18-65 years (Arms 1,2,5,6,9,10);
  • BMI 18-30kg/m2 (Arms 1,2,5,6,9,10);
  • males and females aged 45-75 years with confirmed stable PAD (Arms 3,4,7,8,11,12);
  • on a stable dose of statin, aspirin or clopidogrel for at least one month prior to the study (Arms 3,4,7,8,11,12);
  • BMI 17.5-35kg/m2 (Arms 3,4,7,8,11,12).

You may not qualify if:

  • patients with pain at rest and/or local complications;
  • history of any cardiovascular event within the previous 6 months;
  • treatment with drugs potentially affecting coagulation time or platelet aggregation (except aspirin or clopidogrel);
  • evidence of hepatic or renal impairment;
  • history of bleeding disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Gainesville, Florida, 32605, United States

Location

Unknown Facility

Cincinnati, Ohio, 45219, United States

Location

Unknown Facility

Cincinnati, Ohio, 45227, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Heidelberg, 3084, Australia

Location

Unknown Facility

Gatineau, Quebec, J8Y 6S9, Canada

Location

Unknown Facility

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

inclacumab

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

September 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(4)CA(2)AU(1)